Status:

COMPLETED

Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Lead Sponsor:

Johnson & Johnson Surgical Vision, Inc.

Conditions:

Cataract

Corneal Astigmatism

Eligibility:

All Genders

22+ years

Phase:

NA

Brief Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.

Eligibility Criteria

Inclusion

  • be at least 22 years old
  • have cataracts in both eyes
  • have a certain degree of astigmatism in at least one eye
  • sign the written informed consent
  • be willing and able to comply with examination procedures
  • understand, read and write English to complete informed consent and questionnaires
  • be available for study follow-up visits
  • Both eyes must qualify to be eligible to participate in the study

Exclusion

  • Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
  • Have a certain disease/illness such as poorly-controlled diabetes
  • Have certain ocular conditions such as uncontrolled glaucoma
  • Taking medication that may affect subject vision
  • Have irregular corneal astigmatism
  • Pregnant, plan to become pregnant during the study, or is breastfeeding

Key Trial Info

Start Date :

December 13 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 8 2022

Estimated Enrollment :

475 Patients enrolled

Trial Details

Trial ID

NCT03791619

Start Date

December 13 2018

End Date

August 8 2022

Last Update

August 29 2023

Active Locations (23)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (23 locations)

1

Empire Eye & Laser Center

Bakersfield, California, United States, 93309

2

Southern California Eye Physicians & Associates

Long Beach, California, United States, 90805

3

Santa Monica Eye Medical Group

Santa Monica, California, United States, 90404

4

Wolstan & Goldberg Eye Associates

Torrance, California, United States, 90505